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A Multi-Country Analysis of Patients with Chronic Myeloid Leukemia

Principal Investigator:

Devin

Gary

This application is based on a study that was originally carried out and completed at George Washington University. All of the data for this study has been collected. No new data will be collected at JHU or KKI. In addition, all of the data that has been, or will be analyzed is /will be completely de-identified. No PHI associated with this data will be seen by any team member of this study.

The proposed study aims to provide a descriptive assessment of patients with Chronic Myeloid Leukemia (CML) among developing countries participating in the Gleevec International Patient Assistance Program (GIPAP). CML is relatively rare among pediatric patients and preliminary data suggest that the rates of CML are higher among patients from developing countries. GIPAP is a patient access program sponsored by Novartis Oncology to provide Imatinib free of charge to patients in developing countries who could not otherwise afford the treatment. The Max Foundation (TMF) is a non-profit organization that provides logistical support for the enrollment and distribution of drug on behalf of Novartis. TMF maintains a registry of patient characteristics. We are proposing to utilize the data to describe the distribution of CML in developing countries participating in GIPAP since 2002. Over 30,000 patients have been treated globally through GIPAP. This descriptive assessment will be the first large scale epidemiological study of pediatric CML in developing countries.

Research activity will be a thorough literature review conducted by all individuals to describe the current understanding of the epidemiology of CML among pediatric patients. In addition, descriptive epidemiological data analyses will be conducted to describe the epidemiology of CML among pediatric patients in GIPAP. Once the literature review and data analyses are completed, a manuscript will be prepared describing the results.

The following steps will be taken to ensure that the database is secure and destroyed as soon as it is no longer needed:

The database will be in a password protected Excel file containing a statement saying that data is confidential and is only to be used for analyses pertaining to the objectives outlined in the research plan.

The dataset will contain randomly generated patient IDs to distinguish patients from each other.

Other data elements include gender, country of treatment, financial attributes, date of diagnosis, date of birth, phase of disease at baseline, date of first treatment and adverse events.The following will not be included: Participant names, social security number or the equivalent, zip code, address, phone number or other participant identifiers.

Importantly, the data that was chosen to be sent will be completely independent of TMF databases and will not be able to be traced back to the source.

TMF did not obtain informed consent from participants. Source data will not be sought from the individual centers and the analyses will be based only on aggregate data. Individual participants will not be highlighted as this is a descriptive epidemiological study assessing global trends. The investigative team will not have any contact with participants. At the conclusion of the research, the database will destroyed from the hard drive as well as any backed up files.